Bio Pharma Dive
MAY 31, 2023
The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.
Pharmaceutical Technology
MAY 31, 2023
XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.
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Bio Pharma Dive
MAY 31, 2023
The company’s experimental treatment for myotonic dystrophy became the latest neuromuscular disease therapy to face a regulatory roadblock before the start of human testing.
Pharmaceutical Technology
MAY 31, 2023
Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
MAY 31, 2023
The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.
Pharmaceutical Technology
MAY 31, 2023
The University of Sydney and Australian company Pharos Therapeutics have reached an agreement to leverage artificial intelligence (AI) to progress drug discoveries for the treatment of cancer and rare diseases. The university and Pharos have drawn up a memorandum of understanding (MoU) to use AI technology to identify potential compounds for the rapid development of treatments.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 31, 2023
ZNA-1041 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Rethinking Clinical Trials
MAY 31, 2023
Dr. John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients w
Pharmaceutical Technology
MAY 31, 2023
BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. According to GlobalData, Phase II drugs for Ulcerative Colitis have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BBT-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Pharma Mirror
MAY 31, 2023
In the face of increasing global health challenges, the development and production of vaccines have become paramount. One critical aspect is the ability to scale up manufacturing processes to meet the growing demand for viral vector-based vaccines. In this article, we will explore the efforts being made by innovative biotechnology companies to develop scalable and cost-effective manufacturing methods.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
MAY 31, 2023
Anocca has raised SEK 400 million ($36.7 million) in an equity financing round that will be used to move the company’s cell therapy candidates into the clinic in 2024, based on a 31 May press release. The funding will also be used to work on Anocca’s cell therapy discovery and manufacturing process. The round was led by the Swedish pension fund AMF and the investment firm Mellby Gård.
Rethinking Clinical Trials
MAY 31, 2023
Save the date! The NIH Pragmatic Trials Collaboratory will host a virtual workshop June 20-21, 2023, to explore the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems. The workshop, Getting the Right Evidence to Decision-Makers Faster , will kick off on Tuesday, June 20, at 11:00 a.m.
Pharmaceutical Technology
MAY 31, 2023
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Its favourable properties for penetrating the human brain increase intracranial activity.
Fierce Pharma
MAY 31, 2023
Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
MAY 31, 2023
GRANITE-001 is under clinical development by Gritstone Bio and currently in Phase II for Adenocarcinoma Of The Gastroesophageal Junction. According to GlobalData, Phase II drugs for Adenocarcinoma Of The Gastroesophageal Junction have a 51% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how GRANITE-001’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
XTalks
MAY 31, 2023
Warnings against high sodium intake, particularly table salt, have been consistently issued by the World Health Organization (WHO) and numerous health-promoting organizations. Now, there’s a fresh perspective from a new study that highlights not only the effects of high sodium on hypertension, but also its correlation with emotional and cognitive impairment.
Pharmaceutical Technology
MAY 31, 2023
ATRN-119 is under clinical development by Aprea Therapeutics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ATRN-119’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Fierce Pharma
MAY 31, 2023
FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Pharmaceutical Technology
MAY 31, 2023
Sym-021 is under clinical development by Les Laboratoires Servier and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Sym-021’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Fierce Pharma
MAY 31, 2023
After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. | After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.
Pharmaceutical Technology
MAY 31, 2023
Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Phase III drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.
ProRelix Research
MAY 31, 2023
Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared first on ProRelix Research.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Pharmaceutical Technology
MAY 31, 2023
Fruquintinib is under clinical development by Takeda Pharmaceutical and currently in Phase II for Triple-Negative Breast Cancer (TNBC). According to GlobalData, Phase II drugs for Triple-Negative Breast Cancer (TNBC) have a 24% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Fruquintinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
XTalks
MAY 31, 2023
An initial public offering (IPO) is the process through which a privately held company offers its shares to the public for the first time, transforming into a publicly traded company. In the biotech industry, a biotech IPO refers to a specific case where a biotechnology company goes public and lists its shares on a stock exchange. This allows the company to raise funds from public investors.
Outsourcing Pharma
MAY 31, 2023
A small molecule drug candidate from Algiax Pharmaceuticals can reduce excitability of neurons in relation to chronic pain, dampening signal and reducing pain, a study shows.
Pharma Times
MAY 31, 2023
The inflammatory form of arthritis is estimated to affect nearly 38 million people worldwide
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Fierce Pharma
MAY 31, 2023
Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal. | Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal.
pharmaphorum
MAY 31, 2023
ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research Mike.
Pharma Times
MAY 31, 2023
The neurological disease affects approximately 2.
pharmaphorum
MAY 31, 2023
PM Society’s ‘Securing Market Access to Medicines for England, Ireland, Scotland & Wales’ – part one Mike.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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